Resistant MigraineRECLAIM-IINCT07719608
A Pivotal Clinical Study to Evaluate the MySalvia System for the Treatment of Resistant Migraine
A study testing Neurostimulator in people with Resistant Migraine and Chronic Migraine Headache, run by Salvia BioElectronics at 3 sites in United States.
Trial summary
The purpose of this pivotal clinical study is to evaluate the safety and effectiveness of the MySalvia System, a minimally invasive implantable neuromodulation therapy, for the preventive treatment of adults with resistant migraine. Read more about this study
- Who is it for?
- Ages 22 to 84 years
- Conditions the study is for
- Resistant Migraine, Chronic Migraine Headache, Headache (Migraine)
- What is being tested?
- Neurostimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Dec 2026to 1 May 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets resistant migraine criteria:
- Documented diagnosis of 1.1 migraine without aura and/or 1.2 migraine with aura and/or 1.3 chronic migraine according to ICHD-3
- Headache requiring two of the following:
- Leads to considerable impairment in personal, educational and/or occupational areas of functioning (MIDAS rating of severe or very severe)
- Concomitant continuous or near continuous headache between migraine attacks
- Eight or more monthly migraine days
- Lack of 50% reduction in monthly migraine days and/or intolerable side effects and/or absolute contraindication to three or more (but not all) classes of at least one evidence-based medication. The classes must include Onabotulinumtoxin A and CGRP mabs/antagonists.
- Not better accounted for by another ICHD-3 diagnosis 4. History of migraine onset before 50 years of age 5. Stable dose of all preventive migraine medication(s) and alternative therapies for at least three months before the start of the eligibility phase
Who cannot join
- Presence of another chronic primary or secondary headache disorder, unless the participant can reliably differentiate these headaches attacks from migraine attacks, based on the pain characteristics and associated symptoms
- Concurrent use of any invasive or non-invasive neuromodulation.
- Previous inadequate response to an implantable neuromodulation device for headache or pain management.
- Have an existing active implantable medical device nearby the implant location (e.g. DBS, cochlear implant).
- Use of onabotulinum toxin A injections for the treatment of migraine in the past 3 months.
- Presence of an active implantable medical device (e.g. pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implant).
- Presence of metal or magnet implants in the skull or cranial region (e.g. skull plates, seeds)
- Pregnant, nursing or not using contraception.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Queen City Clinical Research, PLLC
Charlotte, North Carolina, 28211
Shannon Hill, Director of Clinical Research, 704-405-6150, recruitment@qccresearch.com
Leo Kapural, MD
- Recruiting
Vista Clinical Research
Newnan, Georgia, 30265
Debra Helton, CCRC, MLT, 770-755-6914, dhelton@vistaclinresearch.com
Sandeep Vaid, MD
- Recruiting
MedStar Health Research Institute
Olney, Maryland, 20832
Meselu Amare, Clinical Research Coordinator II, 301-570-8508, Meselu.B.Amare@medstar.net
Dr. Jessica Ailani, MD
About this study
Official title: Randomized, Double-Blind, Controlled Pivotal Trial of the MySalvia System for the Treatment of Resistant Migraine
The purpose of this pivotal clinical study is to evaluate the safety and effectiveness of the MySalvia System, a minimally invasive implantable neuromodulation therapy, for the preventive treatment of adults with resistant migraine.
- Being tested
- Neurostimulator
- Keywords
- Neuromodulation, Chronic Migraine, Resistant Migraine, Headache, HIgh Frequency Episodic Migraines
- Medical subject headings
- Migraine Disorders, Cluster Headache, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurostimulatorDevice
A neurostimulation system that consists of implantable and non-implantable components that work together to deliver mild electrical signals to targeted craniofacial nerves.
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Active comparator | Not described Receives: Device: Neurostimulator |
| Active Control Group | Active comparator | Not described Receives: Device: Neurostimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint - Efficacy
Proportion of participants achieving a ≥30% reduction in Monthly Migraine Days (MMD) at 24 weeks post device activation compared to baseline.
Measured: 24 weeks
Primary Outcome Measure - Safety
Incidence of serious procedure-, device- and/or stimulation-related adverse events among all participants at 24 weeks post-device activation.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salvia BioElectronics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719608
- Sponsor's protocol ID
- SCI-05-RM
- Acronym
- RECLAIM-II
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes